NCT06933277

Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients

Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 159 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is an observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy. A minimum of 159 patients is required. Overall study duration is estimated in 36 months.

Detailed description

This is a non-interventional, national, multicenter prospective and retrospective observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy. All the sites participating in the study are using SVd in clinical practice. According to sample size calculation, a minimum of 159 patients is required. Overall study duration is estimated in 36 months: 24 months on enrolment and at least 12 months of observation.

Conditions

• Multiple Myeloma

Timeline

• Start date: 2025-08-29
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-04-18
• Last updated: 2025-09-10

Locations

1 site across 1 country: Italy